The OMELETTE study is a randomised, controlled, unicentric, open-label study to prove the noninferiority of reduced prone position (PP) sessions (more tan 16 hours) versus prolonged PP (48 hours).
This is a non-comercial, investigator-driven clinical study developed in a single critical care unit. The study is coordinated by the main investigator from Hospital Universitario 12 de Octubre in Madrid; The sponsorship is performed by Dr. Ignacio Sáez (Hospital Universitario 12 de Octubre). The study was planned according to the Good Clinical Practices. Omelette study has been approved by the Ethics Committee. All participating Patients must give informed consent before any study procedure occur.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
PP according to previous study
Hospital 12 de Octubre
Madrid, Spain
Ventilator-free days at 28 days
Number of days from successfully weaning to day 28
Time frame: 28 days
Ventilator-free days at 60 days
Number of days from successfully weaning to day 60
Time frame: 60 days
Survival
Mortality during ICU or hospital admission
Time frame: 60 days
ICU and Hospital stay
Days of stay
Time frame: Hospital admission
Evolution of respiratory parameters
Measurement of mechanical ventilation parameters.
Time frame: ICU admission
PP complications
Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event.
Time frame: ICU admission
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